NCT Number: NCT00006405
APEX: Adiposity Prevention by Exercise in Black Girls
To determine whether a one year afternoon exercise program will reduce adiposity in African American girls, ages 8 to 10.
Looking for future studies?
Notify MeKey information
Conditions
Age range
8 year–10 year
Sex eligibility
Female
Study type
Observational
About this study
BACKGROUND:
Obese children who engage in vigorous exercise programs show beneficial effects on total body percent fat (percent BF) and visceral adipose tissue (VAT); however, little is known about how to prevent accretion of total body or visceral adiposity in high risk youths, such as African-American (AA) females.The project has important health implications for two reasons, as follows. There is a dearth of information concerning the effects of exercise interventions in school and community settings. If the study shows that an afternoon exercise program reduces accretion of general and visceral adiposity and has a favorable impact on fitness and health in a population that is at high risk of obesity, then schools may be encouraged to implement similar interventions to prevent juvenile obesity and associated health problems.
The study was awarded in response to a Program Announcement on Physical Activity and Cardiopulmonary Health released in October 1994 jointly by the NHLBI, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute of Nursing Research.
DESIGN NARRATIVE:
The design involves randomization of 200 African American girls, eight to 10 years of age into intervention or control groups. After one year, the groups are compared to test the primary hypothesis that a one year afternoon exercise program will reduce accretion of general and visceral adiposity in these girls. Then the girls will switch group assignments for the next year. The pattern of data over the three time points will show what happens over a two year period in which the youths are, or are not, involved in the exercise program. The measurements will include: (1) percent body fat with dual-energy x-ray absorptiometry; (2) visceral adipose tissue (VAT) with magnetic resonance imaging; (3) cardiovascular fitness with a multi-stage treadmill test; (4) cardiovascular disease (CVD) risk factors (i.e., the ratio of total to high density lipoprotein cholesterol, insulin, systolic blood pressure, and fibrinogen); (5) free-living exercise and diet; (6) psychosocial variables (i.e., self-efficacy and self-concept); (7) sexual maturation; (8) anthropometric measures. The exercise program will be implemented in neighborhood schools for 90 minutes each weekday afternoon. Transportation will be provided if needed. Sessions will include motor skill instruction and aerobic exercises.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
No eligibility criteria
Treatment and study plan
Sponsors and collaborators
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Nih
Registry information
Important dates
- Study start
- 2002
- Primary completion
- 2007
- Study completion
- 2007
- First posted
- Oct 13, 2000
- Registry last updated
- Jan 21, 2008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Defining an Obesity QTL on Chromosome 3q
NCT00087919
Body Weight, Cardiovascular Diseases
View Trial DetailsPhysical Activity and Cardiovascular Risk in Black Girls
NCT00005437
Body Weight, Cardiovascular Diseases
View Trial DetailsGirls Health Enrichment Multi-Site Studies (GEMS)
NCT00000615
Body Weight, Cardiovascular Diseases
View Trial DetailsWorksite Program to Prevent Weight Gain Among Bus Drivers
NCT00122993
Body Weight, Cardiovascular Diseases
Minneapolis, Minnesota, United States
View Trial Details